ClinicalTrials.gov record NCT07602205

Efficacy and Safety of Daily Home-based Hyperthermic Baths for Reducing Epileptic Seizures in CDKL5 Deficiency Disorder: A PROBE Clinical Trial

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

Efficacy and Safety of Daily Home-based Hyperthermic Baths for Reducing Epileptic Seizures in CDKL5 Deficiency Disorder: A Prospective, Randomized, Parallel-Controlled, Open-Label, Blinded Endpoint (PROBE) Clinical Trial

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age6 months old to 14 years old

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized study compares daily, home-based hyperthermic baths plus usual antiseizure care with usual care alone for children with CDKL5 deficiency disorder who have epileptic seizures. The bathing intervention is given daily for 12 weeks and seizure frequency and safety are measured. Outcomes are assessed by blinded endpoint reviewers.

What it is studying. The study is testing whether adding a daily home hyperthermic bath (20 minutes at 40–42°C) to usual antiseizure care changes seizure burden and is safe compared with usual care alone. The main measured outcome is the proportion of participants achieving at least a 50% reduction in seizure frequency over the 12‑week bathing period; other measures include change in seizure frequency and seizure-free days.

What the researchers hope to learn. To find out whether daily home hyperthermic baths affect seizure frequency, the proportion of people who have a ≥50% seizure reduction, the number of seizure‑free days, and to collect safety information in CDKL5 deficiency disorder.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The primary objective of this research is to study the efficacy and safety of daily, home-based hyperthermic baths for reducing epileptic seizures in CDKL5 Deficiency Disorder.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Behavioral: Home-based hyperthermic Baths

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

A diagnosis of CDKL5 deficiency disorder, including molecular confirmation of a pathogenic CDKL5 variant and exhibiting epileptic seizures.
Male or female participants aged 6 months to 14 years, inclusive.
Patients presenting with drug-resistant epilepsy that seizures were uncontrolled despite the appropriate trial of at least two antiseizure medications (ASMs).
At least 8 motor seizures during each 4 weeks in the 8-week historical seizure records preceding screening.
Treatment regimens of 0-4 ASMs were required to be stable for at least 4 weeks before screening and throughout the intervention. Ongoing ketogenic diets were allowed if remain unchanged during screening and treatment.
Subjects who have undergone surgical implantation of vagus nerve stimulation (VNS) will be eligible for inclusion in the study, provided they meet all of the following criteria:
The VNS device has been in place for at least one year prior to the screening visit;
The stimulation parameters remain unchanged throughout the duration of the trial.
Parents or caregivers must be able and willing to maintain an accurate and comprehensive daily electronic seizure diary throughout the duration of the study.
Participants' legal guardians willing to provide written informed consent.

Exclusion criteria

Patients who had any history of previous brain disease (including trauma, encephalitis, etc.) that were likely to precipitate seizures; defined by MRI outcomes.
Participants with skin ulceration or dermatologic conditions that make bathing unsuitable.
Parents or guardians who, based on past experiences, determine that the child has an intolerance to thermal baths.
A history of seizures induced by thermal baths, or an increase in seizure frequency after thermal baths.
Patients who presented any clinical condition that in the opinion of the principal investigator made the patient not suitable to participate in the survey.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is a prospective, randomized, open-label, blinded-endpoint study designed to evaluate the efficacy and safety of daily home-based hyperthermic bathing in participants with CDKL5 deficiency disorder. Eligible participants will be randomized in a 1:1 ratio to receive either hyperthermic baths in addition to usual antiseizure care or usual antiseizure care alone without hyperthermic baths. Efficacy will be assessed primarily by changes in epileptic seizure burden, and safety will be evaluated throughout the study period.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After screening (including review of 8 weeks of prior seizure records and medical history), children are randomized 1:1 to either daily home-based hyperthermic baths plus usual antiseizure care or to continue usual antiseizure care without baths. The bath intervention is daily immersion in 40–42°C water for 20 minutes under continuous parental supervision for 12 weeks. Caregivers must keep an accurate electronic daily seizure diary throughout the study; safety and seizure frequency are monitored from baseline through the 12-week period. Antiseizure medications and, if used, ketogenic diet and VNS settings must remain unchanged during the intervention period.

How the study is structured. A prospective, randomized, open-label trial with blinded endpoint assessment. Participants are assigned 1:1 to receive either daily home hyperthermic baths plus their usual antiseizure care or to continue usual care without baths. The intervention period is 12 weeks of daily 20-minute baths (40–42°C); seizure and safety outcomes are recorded from baseline to week 12.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on CDKL5 deficiency disorder

This trial is also listed on this site under Dravet syndrome.

Clinical trials22 trials listed for CDKL5 deficiency disorderEvery trial the registry lists for CDKL5 deficiency disorder, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in CDKL5 deficiency disorder researchLatest monthly update: September 2026. Includes: EEG background changes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Aug 1, 2026 (estimated)
Primary completion: Dec 31, 2027 (estimated)
Study completion: Dec 31, 2027 (estimated)
Target enrollment: 34 participants (estimated)
Last updated on registry: May 22, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Xuanwu Hospital, Beijing
Principal investigator: Liankun_Ren, Professor
Xuanwu Hospital, Beijing

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Liankun Ren, MD, PhD 📞 +86 13681576621 ✉ renlk2022@outlook.com

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

primary objective: The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
before screening: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
MRI: A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
principal investigator: The doctor or scientist responsible for running the study at a site or overall.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
randomized: Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
open-label: No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
blinded: Who does not know which intervention a participant is receiving. It can apply to participants, the people giving the treatment, those assessing results, or those analysing the data.
endpoint: Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
1:1: How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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